UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005137 |
|---|---|
| Receipt number | R000006093 |
| Scientific Title | Examination of clinical utility of XX-45(double-balloon enteroscope) |
| Date of disclosure of the study information | 2011/02/25 |
| Last modified on | 2011/02/25 09:46:09 |
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Basic information
Public title
Examination of clinical utility of XX-45(double-balloon enteroscope)
Acronym
Examination of clinical utility of double-balloon enteroscope
Scientific Title
Examination of clinical utility of XX-45(double-balloon enteroscope)
Scientific Title:Acronym
Examination of clinical utility of double-balloon enteroscope
Region
| Japan |
Condition
Condition
Patients for whom endoscopic observation of the depth of the small bowel is considered necessary,corresponding to any of the following:
- Patient with suspected Obscure
Gastrointestinal Bleeding(OGIB)
- Patient with suspected overt small
intestinal bleeding
- Patient with suspected small
intestinal diseases below;
Crohn's dsease,erosion,nulcer,
malignant tumour,benign tumour,
polyp,inflammatiom,diverticulum,
angiodysplasia,stenosis,
malabsorption syndrome,protein-
losing gastroenteropathy
- Patient requiring the removal of
foreign bodies in the small bowel
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examine the safety and efficacy of XX-45 in the patients who require endoscopic observation of the small bowel.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
- Whether or not the objectives of the
examination were achieved
- Incidence of adverse events
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Insertion of XX-45 via an oral and/or anal route
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 13 | years-old | <= |
Age-upper limit
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Age::13 to 79 years old
Gender::Not specified
Inpatient/outpatient:Not specified
Key exclusion criteria
1)Patients with acute abdomen
2)Patients with severe acute inflammation
3)Patients with anaphylaxis to natural rubber
4)Patients in a very bad general condition
5)Patients with suspected intestinal perforation
6)Patients having severe blood clotting defect
7)Patients with severe hepatic function disorder
8)Patients with severe respiratory diseases or circulatory diseases
9)Gravida and possibly pregnant patients
10)Patients who have participated in other clinical trials within 3 months prior to the start of this trial.
11)Patients who do not have the capacity or intention to cooperate with the trial procedures.
12)Patients who have experienced any adverse reactions through the enteroscopy.
13)Patients, the investigator (or the subinvestigator) considers, inappropriate for entry into the trial.
14)Sick or injured persons in life-threatening conditions and from whom it seems difficult to obtain written informed consent for their participation in the trial.
15)Patients with whom insertion of the endoscope has to be conducted via the stoma.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hironori Yamamoto,M.D,Ph.D |
Organization
Jichi Medical University Hospital
Division name
Endoscopy Center
Zip code
Address
3311-1 Yakushiji, Shimotsuke-shi, Tochigi-ken, Japan 329-0498
TEL
0285-58-7539
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Katsuya Kikuchi |
Organization
FUJIFILM Corporation
Division name
Endoscopy Systems Div.
Zip code
Address
26-30,Nishiazabu 2-Chome Minato-ku,Tokyo 106-8620,Japan
TEL
03-6418-9141
Homepage URL
katsuya_b_kikuchi@fujifilm.co.jp
Sponsor or person
Institute
FUJIFILM Corporation
Institute
Department
Personal name
Funding Source
Organization
FUJIFILM Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
財団法人厚生会 仙台厚生病院（宮城県）
自治医科大学附属病院（栃木県）
日本医科大学付属病院（東京都）
昭和大学藤が丘病院（神奈川県）
名古屋大学医学部附属病院（愛知県）
広島大学病院（広島県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 02 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2008 | Year | 04 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
| 2009 | Year | 07 | Month | 01 | Day |
Date trial data considered complete
| 2009 | Year | 08 | Month | 01 | Day |
Date analysis concluded
| 2010 | Year | 01 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 02 | Month | 25 | Day |
Last modified on
| 2011 | Year | 02 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006093
